InflaRX N.V. (NASDAQ: IFRX) has announced positive findings from the third group of patients in the phase IIa open-label trial with vilobelimab in treating Pyoderm Gangraenosum.
InflaRx to seek FDA guidance on next steps regarding the study
The company’s chief clinical development officer Dr. Korinna Pilz said, “We are happy to see more patients responding with the highest dose of vilobelimab in patients with Pyoderma Gangraenosum. There is a need for better treatment options for this painful and debilitating condition. With the good safety profile and promising efficacy results we have seen in this trial, we will seek FDA guidance on next steps towards a pivotal program.”
The multi-site proof-of-concept trial enrolled 19 patients in all, with seven individuals in the third cohort, as previously disclosed. After an initial run-in phase with three doses of 800mg on days 1, 4, and 8, patients were treated biweekly with vilobelimab 800mg, 1600mg, or 2400mg for a total of 26 weeks.
Upon disease evaluation on day 57, a dose increase to a higher dosing group was permitted provided at least five patients in the cohort had been treated without safety issues, and the patient had a Physician Global Assessment (PGA) score of 4 or above, as per protocol.
Vilobelimab well tolerated in patients
The study’s primary endpoints are to assess vilobelimab’s safety and efficacy in PG patients. In addition, the responder rate, defined as a PGA score of 3 of the target ulcer at various timepoints and time to complete closure (remission) of the target ulcer, is used to assess efficacy.
Vilobelimab was generally well tolerated. Two patients had associated serious adverse reports across all cohorts: one had erysipelas that required hospitalization (though the sponsor ruled it unrelated); the other developed a rash owing to a delayed hypersensitivity reaction and withdrew from the trial. There were no dose-related adverse events (AEs) discovered. Overall, the AE profile found was consistent with the underlying illnesses.
